We are seeking a highly motivated individual to join us as Global Lead, Computer System Validation.
In this role, you will manage Clients Computer System Validation team and assume ownership of this process. With focus on above site/enterprise systems you ensure compliance with the respective procedures and regulatory guidelines. Provide guidance and support to site validation groups tasked with implementation of automated equipment and local systems. This position will be located at the Client headquarters and perform as leader in Clients Quality Engineering department. Reporting to Clients Head of Quality Engineering youll interface and build strong partnerships with IT, Validation, Engineering, Manufacturing, R&D and other parts of Clients organization.
Responsibilities (include, but are not limited to):
Oversee computer system validation for Client.
Manage team of Computer System Validation subject matter experts in Clients QE department.
Support drive of integrated validation program at Client.
Support the change control process for validated systems.
Ensure alignment of automation system qualification at sites with Clients CSV procedures.
Drive computer system compliance aspects across Clients project portfolio.
Partner with peers in the QE department around automation strategies.
Support regulatory inspections and audits.
Establish and manage risk assessment process for computer system validation.
Support vendor qualification and compliance audits.
Review technical/investigation reports as appropriate.
Review and approve proposed changes to systems and procedures, as appropriate.
Track, review and report metric information for use in continuous improvement of areas of responsibility.
Perform other duties as required.
Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).
Automation, equipment and utility IQ/OQ/PQ/PV.
Department or team management/leadership experience.
Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
Strong knowledge of GMP, GAMP, SOPs and quality systems.
Experience with internal and external audit principals.
Strong knowledge of change control practices/strategies.
Proficient in MS Word, Excel, Power Point and other applications.
Strong written and verbal communication skills.
Ability to communicate and work independently with scientific/technical personnel.
Bachelors degree in technical discipline (Computer Science/Engineering or similar).
Minimum of 10 years of Computer System Validation experience in a GMP environment (Drug Substance or Drug Product).
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).
Minimum 7 years of management experience.
Experience in the medical and/or pharmaceutical industry.
ASQ, Black Belt/Green Belt certifications.